UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047166 |
|---|---|
| Receipt number | R000052678 |
| Scientific Title | A randomized controlled trial on the effectiveness of internet-delivered parent-child interaction therapy in children with attention-deficit/hyperactivity disorder |
| Date of disclosure of the study information | 2022/03/16 |
| Last modified on | 2025/03/28 11:29:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A randomized controlled trial on the effectiveness of internet-delivered parent-child interaction therapy in children with attention-deficit/hyperactivity disorder
Acronym
A randomized controlled trial on the effectiveness of internet-delivered parent-child interaction therapy in children with attention-deficit/hyperactivity disorder
Scientific Title
A randomized controlled trial on the effectiveness of internet-delivered parent-child interaction therapy in children with attention-deficit/hyperactivity disorder
Scientific Title:Acronym
A randomized controlled trial on the effectiveness of internet-delivered parent-child interaction therapy in children with attention-deficit/hyperactivity disorder
Region
| Japan |
Condition
Condition
Children diagnosed with attention-deficit/hyperactivity disorder (ADHD) and their caregivers
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effectiveness of I-PCIT on children with ADHD and their caregivers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ECBI (Eyberg Child Behavior Inventory) intensity scale at 16 weeks after starting the treatment
Key secondary outcomes
ECBI intensity scale at 22 weeks after starting treatment and the following rating scale at 16 and 22 weeks after starting treatment
-CBCL(Child Behavior Checklist)
-SESBI-R(Sutter-Eyberg Student Behavior Inventory-Revised)
-ADHD-RS(ADHD Rating Scale-4)
-PNPS(Positive and Negative Parenting Scale)
-BDI-2(Beck Depression Inventory-2)
-PSI-SF(Parental Stress Index-Short Form)
-Confidence in parenting
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
<I-PCIT>
(1) I-PCIT is conducted according to the "Parent-Child Interaction Therapy Protocol 2011". This protocol is translated into Japanese with the permission of Sheila Eyberg et al, the developers of PCIT.
(2)One or two therapists will conduct the I-PCIT. The therapists should have completed the PCIT Initial Workshop. The number of sessions varies from case to case depending on the caregiver's skill level and the child's behavioral status, but the average number of sessions is 12 to 20. The co-therapist monitors the fidelity of the main therapist's procedures and provides feedback based on a treatment completion checklist.
(3) Individualized intervention for each parent and child.
(4)The program consists of two parts. In the first half of the program, Child-Directed Interaction (CDI), caregivers are coached on how to talk to their children through play situations to improve and strengthen parent-child interaction.
(5)After the CDI skills have reached the mastery criteria, we move on to Parent-Directed Interaction (PDI), which focuses on coaching caregivers on how to give effective commands and how to respond consistently when children comply and when they do not. PDI focuses on increasing the child's listening behavior and reducing problem behaviors.
(6) Treatment is terminated when the caregiver's CDI and PDI skills reach the mastery criteria specified in the treatment protocol, the ECBI score is 112 or lower, and the caregiver demonstrates confidence in parenting.
(7) After the completion of the I-PCIT, a follow-up session (one time only, 60 minutes) will be conducted after a period of 6 weeks.
Interventions/Control_2
control group - treatment as usual
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 4 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) The child's age is 4 to 5 years old.
(2) The child was diagnosed as ADHD in DSM-5 by a child psychiatrist or pediatrician.
(3) The child is not receiving any medication or psychotherapy for ADHD or any mental developmental disorder at the time of entry into the study.
(4) The caregiver and the child do not have severe physical disabilities.
(5) The child has externalizing symptoms (aggressive behavior, hyperactivity, etc.), and the caregiver feels some difficulty in raising the child and interacting with the child (ECBI intensity score of 124 or higher).
(6) The caregiver's age is between 20 and 60 years old.
(7) The caregiver is able to speak, read, and write in Japanese and is raising the child in Japanese.
(8) Both caregivers and preschool staff are willing to participate in the study.
(9) Have an Internet environment and devices that allow them to participate in online sessions using a videoconferencing system.
(10) The patient has obtained permission from the attending physician to participate in the study.
Key exclusion criteria
(1) The caregiver has intellectual disability (22 or more wrong answers on JART-25).
(2) The caregiver has serious suicidal ideation (score of 2 or more on BDI-II item 9).
(3) The child has severe autistic tendency. (T score of 76 or more on SRS-2).
(4) When the child has difficulty in understanding simple instructions in daily life.
(5) Cases in which there is abuse that requires urgent attention at the time of initiation of treatment, and in which the perpetrator of domestic violence is living with the child.
(6) Cases of sexual abuse in which the perpetrator is a caregiver who is scheduled to undergo I-PCIT.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Haruo |
| Middle name | |
| Last name | Fujino |
Organization
Osaka University Hospital
Division name
Pediatrics
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3863
fjinoh@kokoro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Kawasaki |
Organization
Japan PCIT Training Center
Division name
Clinical department
Zip code
162-0056
Address
MH Bldg.1F, 9-4, Wakamatsu-cho, Shinjuku-ku, Tokyo
TEL
03-6380-0933
Homepage URL
kawasaki@pcittc-japan.com
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Aoitori Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Research Review Committee
Address
2-2, Yamadaoka, Suita city, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
46
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Primary outcomes
ECBI (Eyberg Child Behavior Inventory) intensity scale at 16 weeks after starting the treatment
Secondary outcomes
ECBI intensity scale at 22 weeks after starting treatment and the following rating scale at 16 and 22 weeks after starting treatment
-CBCL(Child Behavior Checklist)
-SESBI-R(Sutter-Eyberg Student Behavior Inventory-Revised)
-ADHD-RS(ADHD Rating Scale-4)
-PNPS(Positive and Negative Parenting Scale)
-BDI-2(Beck Depression Inventory-2)
-PSI-SF(Parental Stress Index-Short Form)
-Confidence in parenting
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 08 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 14 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052678
